The eyecare industry did not disappoint at the 2023 ASCRS meeting in San Diego, according to many of Ophthalmology Management’s editorial board members. Here’s a selection of the new products that they are looking forward to bringing to their patients.
CATARACT/IOL
Alcon announced that its Argos Biometer is now connected to NGENUITY 1.5. The result: Surgeons can conduct 3D digital image-guided cataract surgery, increasing workflow efficiency and precision. With the NGENUITY 1.5 now available in the United States, ARGOS biometry measurements and images can now be imported to it, enabling cataract surgeons to precisely overlay incision location, capsulorhexis, IOL centration and toric alignment.
Bausch + Lomb’s Apthera IC-8 IOL is the first and only small aperture non-toric EDOF IOL for certain cataract patients who have as much as 1.5 D of corneal astigmatism and wish to address presbyopia at the same time.
“It’s an amazing tool to add to our armamentarium for post-refractive patients and patients who like monovision, as well as complex corneas,” says Blake Williamson, MD.
“There has been a lot of enthusiasm about this technology and its potential,” adds Cynthia Matossian, MD.
B+L’s StableVisc cohesive ophthalmic viscosurgical device and the TotalVisc Viscoelastic System caught Dr. Matossian’s interest. The TotalVisc System includes both StableVisc and the recently launched ClearVisc dispersive OVD. TotalVisc is the only dual pack in the United States that includes a dispersive and cohesive OVD formulated with sorbitol, which has been shown to create a strong physical barrier and deliver free radical-scavenging capabilities.
“TotalVisc also leads the dual pack OVD segment in fill volume of device, with 1 mL of both ClearVisc and StableVisc. This reduces the need to open a second pack mid-procedure, thus contributing to surgical efficiency,” says Dr. Matossian.
Centricity Vision received 510(k) FDA clearance for the ZEPTOLink IOL Positioning System. The new platform integrates the ZEPTO precision pulse capsulotomy technology with any phacoemulsification system to streamline cataract surgery. The company says the platform is the first and only device that creates an instantaneous capsulotomy with consistent, 360-degree IOL overlap for optimal lens positioning and improved outcomes. The ZEPTOLink platform integrates with any phaco system.
Harrow launched the newly FDA-approved Iheezo, a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. Iheezo has been issued a JCode (J2403) and transitional pass-through reimbursement status by CMS. Harrow says it represents the first approved use in the US ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the US ophthalmic market in nearly 14 years.
Lensar’s ALLY Adaptive Cataract Treatment System is designed to fit into any in-office surgery suite and enable the “seamless transition” from femto to phaco performed in a sterile environment, significantly reducing cataract surgery times. Imaging enables automated capsulorhexis centration and tissue-specific femtosecond laser treatment, among other benefits.
Farrell C. Tyson, MD, calls it a “super-fast and compact femtosecond laser for cataract surgery.”
RxSight advertises its Light Adjustable Lens (LAL) as “the first and only [IOL] that can be customized after cataract surgery.” Patients can “test drive” their vision, allowing for custom, LASIK-like refractive precision. The LAL can be adjusted non-invasively through a series of ultraviolet light-based treatments. Errors of up to 2 D of myopic, hyperopic and astigmatic correction can be adjusted, and astigmatism can be corrected down to 0.5 D of cylinder.
“The time has come that the LAL has entered mainstream ophthalmology and has now become a staple in the armamentarium of the refractive cataract surgeon,” says Eric D. Donnenfeld, MD.
ZEISS’s AI IOL Calculator on VERACITY Surgery Planner is a “data-driven IOL power calculation algorithm that uses advanced artificial intelligence and paraxial ray tracing to consistently provide excellent IOL power calculations,” says Dr. Matossian. Available exclusively on the ZEISS VERACITY Surgery Planner as part of the cataract planning solution, the AI IOL calculator “should make A-constants a thing of the past by utilizing more than 16,000 IOL parameters to fine-tune its predictions for each IOL model,” she adds. The ZEISS VERACITY Surgery Planner is cloud-based and designed to streamline and make cataract surgical planning more efficient by merging data from EMRs through integration, diagnostic measurement data from any biometer or topographer and a patient questionnaire to create a suggested surgical plan quickly.
ZEISS’s CT LUCIA 621P is a new aspheric monofocal single piece C-loop IOL. It is the first broad market monofocal IOL from ZEISS to enter the US market as part of the ZEISS Cataract Workflow.
“With a diopter range from 0-34 in 0.5-diopter increments and its patented ZEISS Optic Asphericity Concept, this IOL is designed to treat a wide range of cataract patients,” says Dr. Matossian. “The CT LUCIA 621P comes in a fully preloaded injector to enhance efficiency in the OR.”
CORNEA/OCULAR SURFACE
B + L’s MIEBO (perfluorohexyloctane ophthalmic solution) recently received FDA approval. It is the first and only prescription treatment for signs and symptoms of dry eye disease (DED) that directly targets tear evaporation. One drop is instilled into each eye four times daily. “The drop spreads rapidly across the ocular surface due to its low surface tension and interacts with the lipophilic portion of the tear film that prevents tear evaporation. It also can penetrate the meibomian glands, where it interacts with and dissolves altered meibum in the glands,” says Dr. Matossian.
Trukera Medical’s ScoutPro osmolarity testing system combines specimen collection and lab analysis into one handheld system. Trukera says it is the first and only portable osmometer in the United States, bringing together nanoliter volume sample collection and analysis into a portable device.
CSI Dry Eye is an integrated dry eye assessment, diagnostic, tracking, treatment plan with AI capacity. The software uses evidence-based algorithms to determine the root cause and associations behind DED, according to the company, identifying patterns of abnormalities that can guide doctors in developing an appropriate treatment plan. The software is “ideal for clinicians early to dry eye management, assisting complex data analysis and treatment decisions, tracking response to therapy and integrating the plethora of new dry eye treatments,” says Laura M. Periman, MD
GLAUCOMA
Glaukos announced that the FDA accepted the New Drug Application for the iDose (travoprost intraocular implant), its surgically implanted travoprost delivery vehicle.
“The iDose is a major game changer in the treatment of glaucoma,” says Steven R. Sarkisian, MD. “Several of my patients from the clinical trial for iDose had stable vision in their study eye with the iDose and progression in the non-study eye on eyedrops, even with q3 month follow up and ‘normal’ IOP. This level of control without eyedrops sustained for three or more years is going to bring the practice of interventional glaucoma further than anything else has in years.”
Thea Pharma announced the FDA approved its new drug application for IYUZEH (latanoprost ophthalmic solution) 0.005%, the first clinically proven formulation of latanoprost available in the United States that is preservative-free, for the reduction of elevated IOP in patients with primary open-angle glaucoma (POAG) or ocular hypertension.
Nova Eye Medical’s new canaloplasty device, the iTrack Advance, has been granted FDA 510(k) clearance. It has been green-lighted for microcatheterization and viscodilation to reduce IOP in adult patients with POAG.
REFRACTIVE
Orasis Pharmaceuticals announced that the FDA has accepted for review its New Drug Application for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%), an eyedrop designed to improve near vision in people with presbyopia. The FDA has assigned a Prescription Drug User Fee Act goal date of Oct. 22, 2023. CSF-1 is packaged in single-use vials, and the company says it delivers a 3-line gain starting at approximately 20 minutes after instillation.
Visus Therapeutics presented topline data from the pivotal Phase 3 BRIO-I clinical trial. Brimochol PF, a preservative-free ophthalmic solution for the treatment of presbyopia, met its primary and secondary endpoints, including the prespecified FDA primary endpoint based on the proportion of subjects achieving >15 ETDRS letter gain in binocular near visual acuity (BUCNVA) without a loss of ≥5 letters at distance across all time points through Hour 6 (carbachol P=0.006; brimonidine P=0.039).
B + L’s Technolas Teneo 317z Model 2 excimer laser offers a compact design, a multidimensional eyetracker that operates at 1,740 Hz, more than three times the speed of the laser’s repetition rate, and an ergonomically designed swiveling bed with a wide mattress. The company says treatment involves only three steps, creating a speedy workflow.
“I used the 217z for 20,000+ cases and had my best outcomes and am now waiting for the next generation finally,” says Mitchell A. Jackson, MD.
Johnson & Johnson Vision’s ELITA, its next-generation femtosecond laser, offers low energy per pulse combined with an ultra-fast repetition rate and a smaller spot size of 1 µm, the company says. “The laser produces a consistently smooth stromal bed for an easy flap lift, with little to no manual tissue separation required,” says Dr. Matossian. She notes that additional benefits include an intuitive graphic user interface, quick system startup in under 5 minutes and a simplified maintenance schedule. “The clear, reusable patient interface offers the surgeon good visibility during flap creation, as well as a fixation light during docking and suction break detection.”
STAAR Surgical’s EVO/EVO+ Implantable Collamer Lens for the correction of myopia and myopia with astigmatism provides sharp vision, does not induce the dry eye that can come with contact lens wear and obviates the preoperative peripheral iridotomy required for the previous version of the lens, according to the company. The lens is indicated for use in phakic eye treatment in patients 21 to 45 years of age for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane.
RETINA
Iveric Bio released data from its Phase 3 clinical trials for Zimura (avacincaptad pegol (ACP)), its investigational therapeutic to treat geographic atrophy (GA) secondary to AMD. Zimura achieved its prespecified primary endpoint of reduction in mean growth rate of GA. The company says it is the first such therapy for GA secondary to AMD that has achieved this milestone.
“I was very interested in the approval of a new class of drugs for geographic atrophy [such as Iveric Bio’s and the importance of anterior segment surgeons, who are the gatekeepers for this common disease, to diagnose and refer these patients for treatment,” says Dr. Donnenfeld.
Topcon’s NW500 non-mydriatic retinal camera features fully automated operation, giving clinicians the flexibility to delegate screening to non-clinical staff. Slit scan illumination and a rolling shutter mechanism help to overcome one of the known causes of poorly graded images, effectively imaging smaller pupils, and a 12-megapixel sensor delivers quality color fundus images for clear review and analysis. Touch-screen operation offers rapid capture with just one touch.
“This digital retinal camera and viewing software for placement in primary care offices allows for off-site interpretation via the cloud,” says Dr. Tyson. Another plus, he notes: a 5-year warranty.
MISCELLANEOUS
Lumibird launched two additions to its flagship product, the Tango Reflex Neo: the UltraQ Reflex Neo and Tango Neo. The UltraQ is a fully integrated Q-switched Nd:YAG laser for anterior-segment YAG and glaucoma indications that features second-generation Reflex technology with True Coaxial Illumination, enhancing visualization of anterior and posterior segments, according to Lumibird. New features include a heads-up display with real-time view of treatment settings within the binoculars, joystick control of energy settings and up to 2-mm YAG posterior offset. In addition to the capabilities of its predecessor for YAG and SLT treatments, the Tango Neo offers an improved general user interface with more intuitive control.
The Nanodropper Adapter is a sterile, screw-on adapter for eyedrop bottles that reduces drop volume by approximately 60%, the company says. The result is a drop the correct size for dosing, with wastage, side effects and cost reduced. It fits most medicated eyedrop bottles and is made of a soft, flexible, medical-grade silicone that is gentle on the eye, should contact occur.
“This is a brilliant little idea designed for our patients who go through their drops much faster than their pharmaceutical plan thinks they should,” says Stephanie Becker, MD. “The average patient would hopefully get an extra 2 weeks per bottle — reducing cost due to early refills not being covered by insurance. Simple and brilliant.”
The UFSK International 500 XLE comfort performanceLine treatment chair offers additional, extra-thick padding, removable push handles and armrests, integrated knee roll as well as the flattened neck area — even during procedures lasting several hours. The chair/table combination eliminates the need to transfer the patient. Additional advantages for the physician include maneuverability, a multifunctional handbag with four memory positions and auto-run function, automatic shutdown in standby mode with reactivation button and removable foot control that allows the surgeon to reposition the treatment chair intuitively and without interruption.
“I want an attractive chair that is very comfortable, can accommodate larger patients, is ergonomic and easy to use, and functions as a chair and as an OR bed, says Dr. Becker. The 500 XLE is “hands down the best OR/procedure chair I have ever found.” OM
A version of this article ran online ahead of print.